Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The main questions this study aims to answer are:
- Can participants complete six short brain stimulation sessions per day for five days?
- Is this treatment schedule safe and tolerable for participants?
- What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?
Participants will:
- Complete health screening and baseline assessments.
- Receive six short sessions of magnetic brain stimulation per day for five days.
- Have their brain activity measured using an EEG recording.
- Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.
详细描述
This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting. The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability. About 12 to 16 participants will receive active accelerated iTBS. Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions. The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG. Because this is a small pilot study, the analysis will be mainly descriptive. The results will help refine study procedures and guide the design of a larger future clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
- •Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
- •On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
- •Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
- •Sufficient English proficiency to complete consent and study assessments.
排除标准
- •Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
- •Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
- •Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
- •Enrollment in another interventional trial.
- •Inability to comply with the study schedule.
结局指标
主要结局
Recruitment rate
时间窗: Study recruitment period, up to 12 months
Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
Consent rate
时间窗: Study recruitment period, up to 12 months
Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
Treatment adherence
时间窗: Treatment Days 1 through 5
Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
Retention through Week 12 follow-up
时间窗: Baseline through Week 12
Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
Adverse events
时间窗: Treatment Days 1 through Week 12
Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
Serious adverse events
时间窗: Treatment Days 1 through Week 12
Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
Discontinuations due to adverse events
时间窗: Treatment Days 1 through Week 12
Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
Participant satisfaction with accelerated iTBS
时间窗: Week 2, Week 5, and Week 12
Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale. Scores range from 1 to 5, with higher scores indicating greater satisfaction.
Participant feedback on accelerated iTBS
时间窗: Week 2, Week 5, and Week 12
Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience. Responses will be summarized descriptively.
次要结局
- Exploratory change in clinician-rated depression symptom severity measured by HAMD-17(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in self-reported depression symptom severity measured by PHQ-9(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in self-reported PTSD symptom severity measured by PCL-5(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5(Baseline, Week 2, and Week 12)
- Exploratory change in anxiety symptom severity measured by GAD-7(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in cognitive function measured by MoCA(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in functioning and disability measured by WHODAS 2.0(Baseline, Week 2, Week 5, and Week 12)
- Exploratory change in quality of life measured by Q-LES-Q-SF(Baseline, Week 2, Week 5, and Week 12)
- Baseline clinical global severity measured by CGI-S(Baseline)
- Exploratory change in clinical global improvement measured by CGI-I(Week 2, Week 5, and Week 12)
- Exploratory change in resting-state EEG alpha power(Baseline, Treatment Day 1, and Treatment Day 5)
- Exploratory change in resting-state EEG gamma power(Baseline, Treatment Day 1, and Treatment Day 5)